(255 days)
The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.
The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.
The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).
The Defendo Fujifilm 500/600 Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single use valves designed to be used on the Fujifilm 500/600 series GI endoscopes as accessories. The specific valves include the Defendo Fujifilm 500/600 Single Use Air/Water Valve, the Defendo Fujifilm 500/600 Single Use Suction Valve, the Defendo Fujifilm 500/600 Single Use Biopsy Valve, and the Endoqator Fujifilm 500/600 Single Use Connector.
The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.
The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.
The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.
The Connector allows attachment between the irrigation tube set via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water iet valve.
These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.
The provided FDA 510(k) summary (K232067) describes the acceptance criteria and the study that proves the device meets those criteria for the Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, and Endogator Fujifilm 500/600 Single Use Connector.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide explicit numerical acceptance criteria for each test. Instead, it states that "non-clinical performance testing was performed on the subject device to support the substantial equivalence determination" and concludes that the device "has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use." This implies that the performance of the new devices was within acceptable ranges compared to the predicate devices or met internal engineering specifications for each test.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Air/Water Valve | ||
| Gas (Air and CO2) flow rate testing | Performance comparable to predicate or acceptable flow rates | Met acceptance criteria (implied by overall conclusion) |
| Water flow rate testing | Performance comparable to predicate or acceptable flow rates | Met acceptance criteria (implied by overall conclusion) |
| Backflow prevention testing | Effective backflow prevention comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Force to Disassemble via Axial Pull) | Mechanical forces comparable to predicate or within specifications | Met acceptance criteria (implied by overall conclusion) |
| Button Cycling | Durable operation over repeated cycles comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Suction Valve | ||
| Suction Bypass | Effective suction bypass comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Suction Rate (water and soil) | Suction rates comparable to predicate or within specifications | Met acceptance criteria (implied by overall conclusion) |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Force to Disassemble via Axial Pull) | Mechanical forces comparable to predicate or within specifications | Met acceptance criteria (implied by overall conclusion) |
| Valve Operation / Procedure Duration Test | Durable operation over typical procedure duration | Met acceptance criteria (implied by overall conclusion) |
| Biopsy Valve | ||
| Leak Testing | Minimal leakage comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Insufflation Testing | Effective maintenance of insufflation comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Auxiliary Waterjet Valve (Connector) | ||
| Flow Durability Testing | Durable flow over repeated use | Met acceptance criteria (implied by overall conclusion) |
| Torque Test | Adequate torque resistance for secure connection | Met acceptance criteria (implied by overall conclusion) |
| Packaging | ||
| ISO 11607/ASTM 4169 (sterile barrier) | Sterile barrier maintained after shipping/transit | Maintained sterile barrier (explicitly stated) |
| Biocompatibility | ||
| ISO 10993-1 (for patient-contacting portions) | Biocompatible as per ISO 10993-1 | Subject devices are biocompatible (explicitly stated) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical performance test. It only mentions that "non-clinical performance testing was performed."
The data provenance is from non-clinical performance testing. There is no indication of human data, so country of origin and retrospective/prospective classification are not applicable in this context. These are laboratory/engineering tests performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The performance tests are engineering and materials science tests, not clinical evaluations requiring expert interpretation for ground truth. The "ground truth" for these tests would be objective measurements against established technical specifications or predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the studies were non-clinical performance tests, not clinical evaluations requiring adjudication of subjective assessments. The results would be objective measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a single-use valve/connector for endoscopes, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these non-clinical performance tests would be objective measurements against established technical specifications or the performance of the legally marketed predicate devices. For example, a flow rate test would have a specified minimum/maximum flow, or a leak test would have a maximum allowable leak rate. Biocompatibility utilized ISO 10993 standards.
8. The sample size for the training set
This information is not applicable. This is a medical device accessory undergoing non-clinical performance testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.